UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000397
Receipt No. R000000422
Scientific Title Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Date of disclosure of the study information 2006/04/06
Last modified on 2008/12/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Acronym Phase II study of FEC followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Scientific Title Phase II study of sequential administration of FEC (Fluorouracil / Epirubicin / Cyclophosphamide) followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Scientific Title:Acronym Phase II study of FEC followed by Docetaxel as adjuvant chemotherapy for node-positive breast cancer
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objectives of this study are to verify the disease-free survival with 4 cycles of FEC followed by 4 cycles of docetaxel (DOC) as adjuvant chemothrapy in patients with node positive operable breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes Safety, feasibility

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 4 cycles of FEC (Fluorouracil 500 mg/m2 / Epirubicin 75 mg/m2 / Cyclophosphamide 500mg/m2), every 3 weeks, then 4 cycles•of Docetaxel 70 mg/m2 every 3 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria 1)Histologically proven female breast cancer.
2)Clinical stage T 1-3 N 1-2 M0
3)Incidence of axillary metastasis by lymph node dissection or sentinel node biopsy.
4)> 19 to < 71 years old.
5)ECOG Performance status is 0-1
6)No more than 4 weeks since surgery.
7)No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy is allowed.
8)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
9)Written informed consent
Key exclusion criteria 1) Bilateral breast cancer
2)A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
3)Inflammatory breast cancer
4)Male
5)A history of hypersensitivity reaction to any drugs.
6)Uncontrolled medical conditions.
7)Suspected of infection with fever
8)Severe peripheral neuropathy (>Grade 1).
9)Symptomatic varicella.
10)Treatment required pleural or pericardial effusions
11)Severe peripheral edema.
12)Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
13)Patients who are required concurrent treatment by corticosteroids.
14)Severe psychiatric disorders
15)Pregnant or lactation women, or women with suspected pregnancy
16)Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tamura
Organization Fukuoka University
Division name Internal Medicine, School of Medicine
Zip code
Address 7-45-1,Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tamura
Organization Kyushu Breast Cancer Study Group
Division name Executive office
Zip code
Address 7-45-1,Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-2845
Homepage URL http://www.chotsg.com
Email npo@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization non profit organization Clinical hematology oncology study group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 04 Month 06 Day

Related information
URL releasing protocol http://www.chotsg.com
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 05 Day
Last modified on
2008 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.